Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study
Spectral AI, Inc. - Class A (MDAI)
Company Research
Source: GlobeNewswire
DALLAS, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView™ System for burn indication. Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for use of the DeepView™ System and expects to submit the request in the first half of 2025. Spectral AI's DeepView™ System for burn indication is a predictive medical device that assesses the healing potential of burns by combinin
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News
- Spectral AI (NASDAQ:MDAI) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Spectral AI (NASDAQ:MDAI) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- DeepView™ System Featured at 2025 US Burn ConferencesGlobeNewswire
- Spectral AI (NASDAQ:MDAI) had its price target lowered by analysts at BTIG Research from $3.50 to $3.00. They now have a "buy" rating on the stock.MarketBeat
- Spectral AI Announces 2025 Third Quarter Financial ResultsGlobeNewswire
MDAI
Earnings
- 11/11/25 - Miss
MDAI
Analyst Actions
- 11/12/25 - BTIG
MDAI
Sec Filings
- 11/13/25 - Form 10-Q
- 10/30/25 - Form S-3
- 10/24/25 - Form 8-K
- MDAI's page on the SEC website